Universal CAR-T Cell Therapy for NHL

Bioray Laboratories

Status: Enrolling

Conditions: Non-hodgkin Lymphoma,B Cell

Treatments: Drug: BRL-301

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07248163

2025-BRL-301-02-IIT

Details and patient eligibility

About

This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.

Full description

This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects. Evaluating the safety, tolerability, and efficacy of BRL-301 at a dose level of 5E6/kg.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing to participate in this clinical study and sign an informed consent form;
2. Age ≥ 18 years old;
3. Estimated survival time ≥ 3 months;
4. At least one measurable lesion;
5. CD19 positively expressed;
6. ECOG score 0-1；
7. Hematology, coagulation and biochemistry parameters meeting the requirements;
8. LVEF ≥ 55%;
9. No severe pulmonary disorders;

Exclusion criteria

1. Pregnant or lactating women;
2. Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;
3. Subjects who previously received anti-CD19 targeted therapy;
4. Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;
5. History of Richter's transformation of chronic lymphocytic leukemia (CLL);
6. Presence of uncontrollable fungal, bacterial, viral, or other infections requiring systemic therapy;
7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
8. Severe mental disorders; history of CNS disorders (e.g., epileptic seizure, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any CNS-involved autoimmune disorders);
9. Active autoimmune disorders requiring immunotherapy, including but not limited to end organ damages caused by autoimmune disorders (e.g., Crohn's disease, rheumatoid arthritis, and systemic lupus erythematosus) in the past 2 years, or requiring systemic application of immunosuppressive drugs or other drugs for systemic control of diseases;
10. Primary immunodeficiency;
11. History of other malignancies;
12. Patients with severe cardiovascular disorders;
13. Any circumstances that possibly increase the risk of subjects or interfere with the study results as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Treatment group

Experimental group

Description:

5×10\^6/kgBW

Treatment:

Drug: BRL-301